lonafarnib 50 mg capsule
1 INDICATIONS AND USAGE ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m 2 and above: To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS) For the treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulation Homozygous or compound heterozygous ZMPSTE24 mutations Limitations of Use ZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations. ZOKINVY is a farnesyltransferase inhibitor indicated in patients 12 months of age and older with a body surface area of 0.39 m 2 and above: ( 1 ) To reduce risk of mortality in Hutchinson-Gilford Progeria Syndrome. For treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulation. Homozygous or compound heterozygous ZMPSTE24 mutations. Limitations of Use Not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations. ( 1 )
eiger biopharmaceuticals, inc.
CAPSULE YELLOW LNF 50
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eiger biopharmaceuticals, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING ZOKINVY is supplied as: 50 mg capsules: Size 4 hard capsule, opaque yellow with “LNF” and “50” printed in black. Bottles of 30 capsules each (NDC 73079-050-30) 75 mg capsules: Size 3 hard capsule, opaque light orange with “LNF and “75” printed in black. Bottles of 30 capsules each (NDC 73079-075-30) Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30ºC (59°F-86°F) [see USP Controlled Room Temperature].
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